Agreement builds on and complements Daiichi Sankyo and MSD’s shared commitment to develop novel medicines for patients with cancer

Daiichi Sankyo and MSD to co-develop and co-commercialize MK-6070, an investigational delta-like ligand 3 (DLL3) targeting T-cell engager, worldwide except for Japan where MSD retains exclusive rights

TOKYO & RAHWAY, N.J., August 6, 2024 – Daiichi Sankyo (TSE: 4568) and MSD (tradename of Merck & Co., Inc., Rahway, N.J., USA) (NYSE: MRK) have expanded their existing global co-development and co-commercialization agreement for three investigational DXd antibody-drug conjugates to include MSD’s MK-6070, an investigational delta-like ligand 3 (DLL3) targeting T-cell engager. The companies will jointly develop and commercialize MK-6070 worldwide, except in Japan where MSD will maintain exclusive rights. MSD will be solely responsible for manufacturing and supply for MK-6070.

MK-6070 is a T-cell engager targeting DLL3, an inhibitory canonical Notch ligand that is expressed at high levels in small cell lung cancer (SCLC) and neuroendocrine tumors, currently being evaluated in a Phase 1/2 clinical trial (NCT04471727). The companies are planning to evaluate MK-6070 in combination with ifinatamab deruxtecan (I-DXd) in certain patients with SCLC, as well as other potential combinations. MSD obtained MK-6070 through its acquisition of Harpoon Therapeutics.

“Expanding our oncology pipeline with a DLL3 T-cell engager further supports Daiichi Sankyo’s strategy to create new standards of care for patients with cancer worldwide,” said Ken Takeshita, MD, global head, R&D, Daiichi Sankyo. “We look forward to continuing our relationship with MSD with the addition of MK-6070 as it provides potential synergies with our established antibody-drug conjugate collaboration, particularly ifinatamab deruxtecan, and demonstrates our shared commitment to advancing new medicines for patients.”

“Small cell lung cancer is an aggressive, fast-growing form of lung cancer and new treatment approaches are urgently needed,” said Dr. Dean Y. Li, president, MSD Research Laboratories. “We are pleased to build upon our collaboration with Daiichi Sankyo and look forward to evaluating the novel combination of MK-6070 and ifinatamab deruxtecan in small cell lung cancer and other forms of cancer.”

Financial highlights

Under the terms of the agreement, MSD will receive an upfront cash payment of $170 million and has also satisfied a contingent quid obligation from the original collaboration agreement. The companies will share R&D and commercialization expenses as well as profits worldwide, except for Japan where MSD retains exclusive rights and Daiichi Sankyo receives a royalty based on sales. R&D expenses related to MK-6070 in combination with ifinatamab deruxtecan will be shared in a manner consistent with the original agreement for ifinatamab deruxtecan. MSD will generally record sales for MK-6070 worldwide.

About DLL3

Delta-like ligand 3 (DLL3), a Notch inhibitory ligand, is highly expressed on SCLC and other neuroendocrine tumors such as melanoma, small cell bladder cancer and metastatic castration resistant prostate cancer and is minimally expressed in normal tissues. DLL3 is a promising therapeutic target where multiple treatment approaches are being explored.

About MK-6070

MK-6070 is an investigational DLL3 directed tri-specific T-cell engager currently being evaluated in a Phase 1/2 clinical trial as a monotherapy in certain patients with advanced cancers associated with expression of DLL3 and in combination with atezolizumab in certain patients with SCLC. The U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to MK-6070 for the treatment of SCLC in March 2022.

About the Daiichi Sankyo and MSD collaboration

Daiichi Sankyo and MSD entered into a global collaboration in October 2023 to jointly develop and commercialize patritumab deruxtecan (HER3-DXd), ifinatamab deruxtecan (I-DXd) and raludotatug deruxtecan (R-DXd), except in Japan where Daiichi Sankyo will maintain exclusive rights. Daiichi Sankyo is solely responsible for manufacturing and supply.

About Daiichi Sankyo

Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular and other diseases with high unmet medical needs. For more information, please visit www.daiichisankyo.com.

MSD’s focus on cancer

Every day, we follow the science as we work to discover innovations that can help patients, no matter what stage of cancer they have. As a leading oncology company, we are pursuing research where scientific opportunity and medical need converge, underpinned by our diverse pipeline of more than 25 novel mechanisms. With one of the largest clinical development programs across more than 30 tumor types, we strive to advance breakthrough science that will shape the future of oncology. By addressing barriers to clinical trial participation, screening and treatment, we work with urgency to reduce disparities and help ensure patients have access to high-quality cancer care. Our unwavering commitment is what will bring us closer to our goal of bringing life to more patients with cancer. For more information, visit https://www.msd.com/research/oncology/.

About MSD

At MSD, known as Merck & Co., Inc., Rahway, N.J., USA in the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.msd.com and connect with us on X (formerly Twitter), LinkedIn and YouTube.

Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA

This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2023 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

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Media Contacts:

MSD

Robert Josephson

(203) 914-2372

Daiichi Sankyo

Global/US Media

Jennifer Brennan

(908) 900-3183

jennifer.brennan@daiichisankyo.com

Japan Media

DS-PR@daiichisankyo.co.jp

Investor Contacts:

MSD

Peter Dannenbaum

(732) 594-1579

Daiichi Sankyo

DaiichiSankyoIR@daiichisankyo.co.jp

Clesrovimab met all primary safety and efficacy endpoints

RAHWAY, N.J., July 23, 2024 – MSD (tradename of Merck & Co., Inc., Rahway, N.J., USA) (NYSE: MRK) today announced positive topline results from its Phase 2b/3 clinical trial (MK-1654-004) evaluating clesrovimab (MK-1654), the company’s investigational prophylactic monoclonal antibody designed to protect infants from respiratory syncytial virus (RSV) disease. In the trial, clesrovimab met its primary safety and efficacy endpoints, including reducing medically attended lower respiratory infections (MALRI) caused by RSV through Day 150. Detailed findings of the study will be presented at an upcoming scientific congress and MSD plans to file these data with global regulatory authorities.

“RSV is highly contagious and can cause inflammation in the airways of infants leading to difficulty breathing. As a widespread illness globally, RSV is the leading cause of hospitalization for healthy infants,” said Dr. Paula Annunziato, senior vice president, infectious diseases and vaccines, Global Clinical Development, MSD Research Laboratories. “We are encouraged by these findings and look forward to working with regulators to provide a new option to help address the impact of RSV on infants and their families.”

About MK-1654-004

MK-1654-004 (NCT04767373) is a Phase 2b/3 double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of clesrovimab in healthy preterm and full-term infants. Participants were randomized to receive either a single dose of clesrovimab or placebo. The primary endpoints include the incidence of participants with RSV-associated medically attended lower respiratory infection (MALRI) from Day 1 (post dose) to Day 150 as compared to placebo and safety. Safety measures assessed included the percentage of participants with any injection-related adverse events (AEs), AEs of special interest (AESIs) solicited systemic AEs, or serious adverse events (SAEs).

About Clesrovimab (MK-1654)

                Clesrovimab (MK-1654) is an investigational extended half-life monoclonal antibody (mAb) developed as a passive immunization for the prevention of RSV-associated medically attended lower respiratory infection (MALRI). Clesrovimab is being studied in infants (pre-term and full-term) to provide rapid, durable protection through their first RSV season with a single, fixed-dose administration. 

About RSV

            Respiratory syncytial virus (RSV) is a contagious virus that causes widespread seasonal infection with a worldwide burden in infants and older adults. There is high unmet need for preventative options in both healthy and high-risk infants. Globally, it is the leading cause of hospitalization for healthy infants under a year old. RSV can lead to serious respiratory conditions like bronchiolitis and pneumonia, causing an estimated 101,000 deaths a year worldwide in children under five.

About MSD

            At MSD, known as Merck & Co., Inc., Rahway, N.J., USA in the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.msd.com and connect with us on X (formerly Twitter), LinkedIn and YouTube.

Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA

This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2023 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

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MSD Media Contacts:

Julie Cunningham

(617) 519-6264

Kimberly Petrillo

(267) 742-2813

MSD Investor Contacts:

Alexis Constantine

(732) 594-1578

Peter Dannenbaum

(732) 594-1579

Acquisition strengthens and diversifies MSD’s pipeline with the addition of Restoret™, a novel late-phase candidate for diabetic macular edema and neovascular age-related macular degeneration, as well as preclinical candidates

RAHWAY, N.J., July 12, 2024 – MSD (tradename of Merck & Co., Inc., Rahway, N.J., USA) (NYSE: MRK) today announced the completion of the acquisition of Eyebiotech Limited (EyeBio). EyeBio is now a wholly-owned subsidiary of MSD.

“The EyeBio acquisition further diversifies our late-stage pipeline with the addition of a promising candidate based on novel biology and genetics for the treatment of certain retinal diseases,” said Dr. Dean Y. Li, president, MSD Research Laboratories. “We are excited to welcome the EyeBio team and look forward to working together to advance Restoret for the patients that need it.”

EyeBio’s lead candidate, Restoret™ (EYE103), is an investigational, potentially first-in-class tetravalent, tri-specific antibody that acts as an agonist of the Wingless-related integration site (Wnt) signaling pathway. Based on positive results from the open-label Phase 1b/2a AMARONE study in patients with diabetic macular edema (DME) and neovascular age-related macular degeneration (NVAMD), Restoret is scheduled to advance into a pivotal Phase 2b/3 trial to evaluate its potential for the treatment of patients with DME in the second half of 2024.

Additional pipeline candidates include clinical and preclinical assets being developed for the prevention and treatment of vision loss associated with retinal vascular leakage, a known risk factor for retinal diseases.

Transaction details

Under the terms of the agreement, MSD, through a subsidiary, has acquired all outstanding shares of EyeBio. As previously disclosed, this transaction is being accounted for as an asset acquisition. MSD will record a charge of approximately $1.3 billion, or approximately $0.50 per share in the third quarter of 2024, which will be included in non-GAAP results. As a matter of policy, MSD provides updates to its financial outlook once each quarter and will provide an update to its full-year financial outlook when it reports second-quarter 2024 results on July 30.

About Restoret

Restoret is an investigational, potentially first-in-class tetravalent, tri-specific Wnt antibody designed to address unmet medical need in patients with retinal diseases, including diabetic macular edema (DME) and neovascular age-related macular degeneration (NVAMD). Restoret is administered as an intravitreal injection seeking to eliminate vascular leakage in retinal diseases by agonizing the Wnt pathway with the goal of restoring and maintaining the blood-retinal barrier. Preclinical evidence indicates that agonizing the Wnt pathway in the retina may reduce vascular leakage.

About MSD

At MSD, known as Merck & Co., Inc., Rahway, N.J., USA in the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.msd.com and connect with us on X (formerly Twitter), LinkedIn and YouTube.

Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA

This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2023 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

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MSD Media Contacts:

Robert Josephson

(203) 914-2372

Justine Moore

(347) 281-3754

MSD Investor Contacts:

Peter Dannenbaum

(732) 594-1579

Damini Chokshi

(732) 594-1577

RAHWAY, N.J., July 1, 2024 – MSD (tradename of Merck & Co., Inc., Rahway, N.J., USA) (NYSE: MRK) and Orion Corporation (“Orion”) today announced that notice has been provided of the mutual exercise of an option to convert the companies’ ongoing co-development and co-commercialization agreement for opevesostat (MK-5684/ODM-208), an investigational CYP11A1 inhibitor, and other candidates targeting CYP11A1 into an exclusive global license for MSD.

“We are pleased with the progress made to date in our collaboration with Orion, including the initiation of two pivotal Phase 3 trials evaluating opevesostat in certain patients with metastatic castration-resistant prostate cancer,” said Dr. Dean Y. Li, president, MSD Research Laboratories. “We will continue to advance the clinical development program for opevesostat with speed and rigor to help address the needs of patients living with prostate cancer.”

“The conversion of this collaboration into a license agreement allows Orion to focus our resources to progress our other promising development candidates while both remaining well positioned to benefit from the development and potential commercialization of opevesostat and meeting our financial objectives,” said Liisa Hurme, president and chief executive officer, Orion Corporation. “We believe MSD provides the best choice to maximize the potential of opevesostat, a compound discovered by Orion’s scientists, for the treatment of patients with certain types of prostate cancer.”

As previously announced under the companies’ original co-development and co-commercialization agreement, each party was granted an option to convert the co-exclusive license into an exclusive global license for MSD. With the exercise of the option, MSD will gain global exclusive rights to develop and commercialize opevesostat and other candidates targeting CYP11A1 covered by the agreement.

Under the terms of the agreement, Orion is now eligible to receive development milestone payments up to $30 million, regulatory milestone payments up to $625 million and sales-based milestone payments up to $975 million as well as annually tiered royalty payments ranging from a low double-digit rate up to a rate in the low twenties on net sales for any commercialized licensed product. The development and regulatory milestones are determined by the scope of a number of treatment indications and multiple geographies. Annual sales exceeding several billion US dollars would be required to reach the total amount of the sales milestones and higher end of the royalty rate. In addition, as a result of the exercise of the option, MSD will now assume full responsibility for all past and future development and commercialization expenses associated with the candidates covered by the agreement. As a result of the option exercise and MSD’s assumption of expenses, Orion announced it will release €60 million that was reserved in July 2022 to cover Orion’s share of development cost to be accrued from the balance sheet to net sales and operating profit in Q3 2024. Orion will retain responsibility for the manufacture of clinical and commercial supply for MSD. No payment is associated with the exercise of this option.

The exclusive global license is subject to approval under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions, and is expected to become effective in the third quarter of 2024.

About opevesostat and clinical trial program

Opevesostat is an oral, non-steroidal and selective inhibitor of CYP11A1 discovered and developed by Orion and is being investigated for the treatment of hormone-dependent cancers, such as prostate cancer. By inhibiting CYP11A1 activity, opevesostat is designed to suppress the production of all steroid hormones and their precursors that may activate the androgen receptor signaling pathway.

In 2023, MSD and Orion initiated OMAHA1 (NCT06136624) and OMAHA2a (NCT06136650), two pivotal Phase 3 clinical trials evaluating opevesostat in combination with hormone replacement therapy (HRT), for the treatment of certain patients with metastatic castration-resistant prostate cancer (mCRPC).

OMAHA1 is a randomized, open-label Phase 3 trial evaluating opevesostat in combination with HRT for the treatment of patients with later-line mCRPC who have failed one prior new hormonal agent (NHA) and one or two prior taxanes compared to an alternative NHA (abiraterone or enzalutamide). The trial will enroll an estimated 1,200 patients around the world. The primary endpoints are overall survival (OS) and radiographic progression-free survival (rPFS) by androgen receptor ligand-binding domain (AR LBD) mutation status. Secondary endpoints include time to first subsequent therapy (TFST), objective response rate (ORR) and duration of response (DOR).

OMAHA2a is a randomized, open-label Phase 3 trial evaluating opevesostat in combination with HRT for the treatment of patients with front-line mCRPC who have failed one prior NHA compared to physician’s choice of NHA (abiraterone or enzalutamide). The trial will enroll an estimated 1,500 patients around the world. The primary endpoints are OS and rPFS by AR LBD mutation status. Secondary endpoints include TFST, ORR and DOR.

About metastatic castration-resistant prostate cancer

Prostate cancer is the second most common cancer in male patients globally and is associated with a significant mortality rate. Development of prostate cancer is often driven by male sex hormones called androgens, including testosterone. In patients with metastatic castration-resistant prostate cancer (mCRPC), their prostate cancer grows and spreads to other parts of the body, despite the use of androgen-deprivation therapy to block the action of male sex hormones. Approximately 10-20% of patients with prostate cancer are estimated to develop castration-resistant prostate cancer (CRPC) within five years, with at least 84% of these patients presenting with metastases at the time of CRPC diagnosis. Of patients with no metastases at CRPC diagnosis, 33% are likely to develop metastases within two years.

About MSD

At MSD, known as Merck & Co., Inc., Rahway, N.J., USA in the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.msd.com and connect with us on X (formerly Twitter), LinkedIn and YouTube.

About Orion

Orion is a globally operating Finnish pharmaceutical company – a builder of well-being for over a hundred years. We develop, manufacture and market human and veterinary pharmaceuticals and active pharmaceutical ingredients. Orion has an extensive portfolio of proprietary and generic medicines and consumer health products. The core therapy areas of our pharmaceutical R&D are oncology and pain. Proprietary products developed by Orion are used to treat cancer, neurological diseases and respiratory diseases, among others. Orion’s net sales in 2023 amounted to EUR 1,190 million and the company had about 3,600 employees at the end of the year. Orion’s A and B shares are listed on Nasdaq Helsinki.

Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA

This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2023 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

MSD Investor Contact:

Peter Dannenbaum

+1 732-594-1579

MSD Media Contacts:

Robert Josephson

+1 203-914- 2372

Justine Moore

+1 347-281-3754

Orion Investor Contact:

Tuukka Hirvonen

+358 10 426 2721

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IDEA Studios will be strategically located in Asian and European innovation hubs to partner closely with early-stage companies focused on improving patient care

Zurich, June. 18, 2024 – MSD (tradename of Merck & Co., Inc., Rahway, N.J., USA) (NYSE: MRK) announced today the launch of its IDEA Studios, a new initiative led by the MSD Global Health Innovation Fund (MGHIF) and MSD’s regional teams to fund and collaborate with entrepreneurs and early-stage companies focused on delivering transformative health care solutions.

Announced at the HLTH Europe conference, MSD IDEA Studio Asia Pacific and MSD IDEA Studio Europe will combine the company’s industry-leading corporate venture arm with the deep health care expertise of its regional business teams. Strategically located in the vibrant innovation hubs of Singapore and Berlin, respectively, the IDEA Studios will create an entrepreneurial environment and facilitate the cross-pollination of ideas to foster breakthrough initiatives.

“At MSD, we are constantly seeking to apply digital and data science technologies to improve patient outcomes and help accelerate our purpose of saving and improving lives,” said Joseph Romanelli, president of MSD Human Health International. “The launch of MSD IDEA Studios will offer entrepreneurs the opportunity to leverage our deep health care expertise to accelerate their impact and achieve meaningful innovation to improve patients’ lives.”

As part of these efforts, MSD business teams in Asia Pacific and Europe will collaborate closely with MGHIF investors to select and fund local entrepreneurs who are developing innovative health care solutions. The MGHIF plans to invest US $38 million across both regions during the next three years. Key areas of interest within IDEA Studio Asia Pacific include access to vaccinations and cancer therapies. MSD IDEA Studio Europe will look for innovative ways to diagnose disease earlier, monitor patients to enhance medication adherence, and enhance clinical trial recruitment.

“We are excited to build on MGHIF’s track record of growth investing to collaborate with our colleagues in the Asia Pacific and European regions via the MSD IDEA Studio,” said Joel Krikston, managing director venture investments, MGHIF. “We aim to fuel innovative solutions through strategic investments that will ultimately enable better access to medicines and vaccines for patients.”

Those interested in learning more about the IDEA Studios or wishing to apply can visit: https://www.msdideastudio.com

About MSD IDEA Studio Asia Pacific

Based in Singapore, the MSD IDEA Studio Asia Pacific is actively seeking opportunities to fund and partner with entrepreneurs and early-stage companies across the region. Key areas of initial interest include innovative solutions to improving access to vaccinations, and cancer therapies.

About MSD IDEA Studio Europe

Based in Berlin, the MSD IDEA Studio Europe is actively seeking opportunities to fund and partner with entrepreneurs and early-stage companies across the region. Areas of initial interest include innovative ways to enable early diagnosis of disease, remote patient monitoring solutions to enhance medication adherence and applications to streamline clinical trial operations and recruitment.

About MSD

At MSD, known as Merck & Co., Inc., Rahway, N.J., USA in the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable, and healthy future for all people and communities. For more information, visit www.msd.com and connect with us on X (formerly Twitter), LinkedIn and YouTube.

About MSD Global Health Innovation Fund

MSD Global Health Innovation Fund (MGHIF) is a growth investor partnering with innovative digital health and data science companies that facilitate and optimize biopharmaceutical operations with the goal of improving patient care. This investment strategy connects innovative companies with complementary technologies to develop integrated health care solutions. MGHIF has $500M under management and provides growth capital to emerging health care technology companies worldwide while leveraging the vast R&D-based, global resources of MSD. With a vision that data will be the currency in health care, GHIF invests broadly in digital health. MGHIF invests in platform companies with proven technologies or business models where MSD’s expertise and perspectives can accelerate revenue growth and enhance value creation.

Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA

This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2023 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

Media contacts:

Garry Daniels (Singapore)

+(65)9739–9970

Garry.daniels@msd.com

Ariane Malfertheiner (Germany)

+(49)162–3617890

Ariane.maria.malfertheiner@msd.de

Investor contacts:

Peter Dannenbaum

+(732)594-1579

 Peter.dannenbaum@msd.com

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Acquisition includes Restoret™, a novel late-phase candidate for diabetic macular edema and neovascular age-related macular degeneration, as well as a preclinical pipeline targeting retinal diseases

Restoret anticipated to enter pivotal study for diabetic macular edema in the second half of 2024

MSD to acquire EyeBio for a $1.3 billion upfront payment and up to $1.7 billion in future milestone payments for a potential value of $3 billion

RAHWAY, N.J., and NEW YORK, May 29, 2024 – MSD (tradename of Merck & Co., Inc., Rahway, N.J., USA (NYSE: MRK) and Eyebiotech Limited (EyeBio), a privately held ophthalmology-focused biotechnology company, today announced that the companies have entered into a definitive agreement under which MSD, through a subsidiary, will acquire EyeBio.

“We continue to execute on our science-led business development strategy to expand and diversify our pipeline,” said Dr. Dean Y. Li, president, MSD Research Laboratories. “The EyeBio team, under the leadership of Dr. David Guyer and Dr. Tony Adamis, has a strong track record of developing groundbreaking ophthalmology therapies. By combining our strengths, we aim to advance with rigor and speed the development of their promising pipeline of candidates targeting retinal diseases.”

Under the terms of the agreement, MSD, through a subsidiary, will acquire all outstanding shares of EyeBio for up to $3 billion, including an upfront payment of $1.3 billion in cash and a further potential $1.7 billion in developmental, regulatory and commercial milestone payments. The acquisition has been unanimously approved by the EyeBio Board of Directors.

EyeBio is developing a pipeline of clinical and preclinical candidates for the prevention and treatment of vision loss associated with retinal vascular leakage, a known risk factor for retinal diseases. The company’s lead candidate, Restoret™ (EYE103), is an investigational, potentially first-in-class tetravalent, tri-specific antibody that acts as an agonist of the Wingless-related integration site (Wnt) signaling pathway. Based on positive results from the open-label Phase 1b/2a AMARONE study in patients with diabetic macular edema (DME) and neovascular age-related macular degeneration (NVAMD), Restoret is anticipated to advance into a pivotal Phase 2b/3 trial to investigate the treatment of patients with DME in the second half of 2024.

“The EyeBio team has successfully assembled a pipeline of novel candidates with the potential to provide new treatment options for patients with retinal disease,” said Dr. David R. Guyer, chief executive officer and president, EyeBio. “As a subsidiary of MSD, EyeBio will be positioned to tap into the resources and infrastructure needed to support the clinical, regulatory and commercial development of these candidates and help bring them to patients worldwide.”

In addition to augmenting MSD’s pipeline, the acquisition significantly expands the company’s presence in ophthalmology. The EyeBio team and leadership including founders Dr. David Guyer and Dr. Tony Adamis will leverage their experience and world-class expertise as part of MSD to continue their pioneering work to advance the clinical development of Restoret and other ongoing development programs.

“Less than three years ago, EyeBio was hatched to translate Dr. David Guyer’s idea for a potential new therapy for retinal diseases into a reality,” said Kate Bingham, EyeBio board chair and managing partner, SV Health Investors. “This agreement reflects the hard work of the talented EyeBio team, led by Dr. Guyer, who through this agreement have placed Restoret on a defined development path to patients.”

Closing of the proposed acquisition is subject to approval under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions. The transaction is expected to close in the third quarter of 2024 and be accounted for as an asset acquisition. MSD expects to record a charge of approximately $1.3 billion, or approximately $0.50 per share, that will be included in non-GAAP results in the quarter that the transaction closes.

Advisors

Citi acted as financial advisor to MSD in this transaction and Gibson, Dunn & Crutcher LLP as its legal advisors. Centerview Partners LLC acted as financial advisor to EyeBio and Skadden, Arps, Slate, Meagher & Flom LLP as the company’s legal advisors.

About the blood retina barrier and retinal vascular leakage

Several retinal conditions are characterized by both inflammation and breakdown of the inner blood-retinal barrier (iBRB) resulting in vascular permeability and leakage into the neighboring retinal tissue. Vascular leakage is a known risk factor for retinal diseases including diabetic macular edema (DME) and neovascular age-related macular degeneration (NVAMD).

About Restoret

Restoret is an investigational, potentially first-in-class tetravalent, tri-specific Wnt antibody designed to address unmet medical need in patients with retinal diseases, including diabetic macular edema (DME) and neovascular age-related macular degeneration (NVAMD). Restoret is administered as an intravitreal injection seeking to eliminate leakage in retinal vascular diseases by agonizing the Wnt pathway with the goal of restoring and maintaining the blood-retinal barrier. Preclinical evidence indicates that agonizing the Wnt pathway in the retina may reduce vascular leakage.

About EyeBio (Eyebiotech Limited) and its Investors

Eyebiotech Limited (EyeBio) is a clinical-stage, privately held ophthalmology biotechnology company dedicated to developing and delivering a new generation of therapies to protect, restore and improve vision in patients with sight-threatening eye diseases. Founded in August 2021 by David Guyer, M.D., and Tony Adamis, M.D., and SV Health Investors, EyeBio has a leadership team with a world class track record in ophthalmology drug development. With operations in the United States and the United Kingdom, EyeBio is building and advancing a pipeline of ocular therapies that combine scientifically robust targets with innovative translational approaches. To date, EyeBio has raised $130 million. SV Health Investors (Kate Bingham, DBE and Mike Ross, Ph.D.) founded and seeded the company in August 2021 and were joined in February 2022 by co-leads Samsara BioCapital (Srini Akkaraju, M.D., Ph.D.), Jeito Capital (Andreas Wallnoefer, Ph.D.) in raising a $65 million Series A financing round, with funds from MRL Ventures Fund (Olga Danilchanka, Ph.D.), the corporate venture arm of MSD. In November 2023, the Series A round was expanded to $130 million with the addition of new investors Bain Capital Life Sciences (Leonard Feiner (M.D., Ph.D., and Amir Zamani, M.D.), Omega Funds (Bernard Davitian) and Vertex Ventures HC (Christine Brennan, Ph.D.). For more information, please see www.eyebiotech.com.

About MSD

At MSD, known as Merck & Co., Inc., Rahway, N.J., USA in the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.msd.com and connect with us on X (formerly Twitter), LinkedIn and YouTube.

Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA

This news release of Merck & Co., Inc., Rahway, N.J., USA includes statements that are not statements of historical fact, or “forward-looking statements,” including with respect to MSD’s proposed acquisition of Eyebiotech Limited (EyeBio), and readers are cautioned not to place undue reliance on such statements. Such forward-looking statements include, but are not limited to, the ability of MSD and EyeBio to complete the transactions contemplated by the definitive agreement, including the parties’ ability to satisfy the conditions to the consummation of the acquisition contemplated thereby, statements about the expected timetable for completing the transaction, MSD’s and EyeBio’s beliefs and expectations and statements about the benefits sought to be achieved in MSD’s proposed acquisition of EyeBio, the potential effects of the acquisition on both MSD and EyeBio, the possibility of any termination of the definitive agreement, as well as the expected benefits and success of EyeBio’s product candidates. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees that the conditions to the closing of the proposed transaction will be satisfied on the expected timetable or at all, or that any product candidates will receive the necessary regulatory approvals or prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements

Risks and uncertainties include, but are not limited to, uncertainties as to the timing of the acquisition; the possibility that various conditions to the consummation of the acquisition contained in the definitive agreement may not be satisfied or waived; the effects of disruption from the transactions contemplated by the definitive agreement and the impact of the announcement and pendency of the transactions on EyeBio’s business; general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise, except to the extent required by law. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s 2023 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

MSD Investor Contact:

Peter Dannenbaum

+1 732-594-1579

MSD Media Contacts:

Robert Josephson

+1 203-914- 2372

Justine Moore

+1 347-281-3754

EyeBio Media Contact:

Matt Pera

SmithSolve

(219) 628-0258

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Surpasses its goal of reaching 25 million women by 2025

RAHWAY, N.J., May 8, 2024 – MSD (tradename of Merck & Co., Inc., Rahway, N.J., USA) (NYSE: MRK) announced today that MSD for Mothers, the company’s global maternal health initiative, has reached more than 30 million women through programs promoting safe, high-quality, respectful care, surpassing its goal of reaching 25 million women by 2025.

MSD for Mothers supports the company’s work in expanding access to health and accelerating progress toward the United Nations’ Sustainable Development Goal 3 (SDG 3), which aims to ensure healthy lives and promote well-being for all. More specifically, the initiative is focused on creating a world where no woman has to die while giving life by helping to address the first target under SDG 3, reducing the global maternal mortality ratio to less than 70 per 100,000 live births by 2030.

“I am so proud of our company’s long-standing commitment to our MSD for Mothers initiative, which is dedicated to improving maternal health outcomes around the world,” said Allison Goldberg, president of the company’s foundation. “Through MSD for Mothers, we have now helped more than 30 million women access high-quality, life-saving care around pregnancy and childbirth – surpassing our goal of reaching 25 million women by 2025. This milestone serves as a reminder that much work is left to be done, and we remain committed to helping create a world where no woman has to die while giving life.”

Through wide-ranging approaches, MSD for Mothers harnesses the power of public-private collaboration to strengthen health systems and mobilize solutions to address the diverse and unique needs of moms, babies and families worldwide. The initiative’s milestone of 30 million women reached reflects the combined total impact of the programs and partnerships it supports in more than 70 countries, including:

• India, where MSD for Mothers collaborated with the Federation of Obstetric and Gynecological Societies of India (FOGSI) and a consortium of stakeholders across the country to launch Manyata, a quality improvement and certification initiative specifically designed for private maternity providers. This initiative has supported quality improvements in 25 states and Union Territories across India and trained more than 23,000 providers in 2,800 maternity hospitals, delivering quality care to more than 1 million women.
• Brazil, where MSD for Mothers worked with the Sociedade Beneficente Israelita Brasileira Albert Einstein, a leading hospital network, and the Ministry of Health, to implement a new curriculum to train health providers on maternity care protocols. This effort trained 250 health providers and resulted in a 54% decline in the maternal mortality rate in two years in the Pernambuco State.
• Kenya, where, in response to a high unmet need for post-pregnancy family planning (PPFP), MSD for Mothers partnered with Jhpiego, a nonprofit organization affiliated with Johns Hopkins University, to fund a research study – PPFP Choices – facilitating greater access to evidence-based PPFP services throughout Kenya. PPFP Choices led to a 24% increase in PPFP uptake at participating sites.
• Nigeria – the country with the most maternal deaths worldwide – where with Pathfinder Nigeria, PharmAccess Foundation and the Kaduna State Ministry of Health, MSD for Mothers created the Saving Mothers, Giving Life project (SMGL 2.0). This project improved the quality of maternal health care in 25 private health facilities and led to a decrease in maternal and perinatal deaths by 60% and 16%, respectively.
• United States – the only high-income country in which maternal mortality is on the rise – where MSD for Mothers supports a variety of programs to address racial inequities in maternal health outcomes. For example, with the Centers for Disease Control and Prevention (CDC) Foundation, MSD for Mothers created the Hear Her campaign to disseminate critical information on pregnancy and childbirth-related complications, reaching more than 1.5 million people to date across the campaign’s website and social media channels.

To learn more about MSD for Mothers and stay informed on how the initiative is continuing to expand access to high-quality maternal care, please visit MSDforMothers.com.

About MSD

At MSD, known as Merck & Co., Inc., Rahway, N.J., USA in the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.msd.com and connect with us on X (formerly Twitter), LinkedIn and YouTube.

About MSD for Mothers

MSD for Mothers is MSD’s $650 million global initiative to help create a world where no woman has to die while giving life. Applying MSD’s business and scientific resources, the initiative collaborates with partners to improve the health and well-being of women during pregnancy, childbirth and the postpartum period. For more information, visit www.msdformothers.com.

Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA

This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2023 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

Media Contacts:

Leland Laury

(610) 659 – 8856

Olivia Finucane

+44 7881 262476

olivia.finucane@msd.com

Investor Contacts:

Peter Dannenbaum

(732) 594 – 1579

Alexis Constantine

(732) 594 – 1578

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On track to exceed goal of supplying 100 million doses of HPV vaccine to
Gavi-supported countries through 2025

MSD remains committed to providing a reliable supply and equitable access
to our vaccines for people who use them around the world

RAHWAY, N.J., April 25, 2024 – MSD (tradename of Merck & Co., Inc., Rahway, N.J., USA) (NYSE: MRK) today reaffirmed its previously announced commitment to helping Gavi, the Vaccine Alliance, through an agreement with UNICEF, in achieving its goal of vaccinating millions of girls against Human Papillomavirus (HPV) by 2025 by providing access to its HPV vaccine in low- and middle-income countries where the burden of disease is the highest.

MSD has updated its initial commitment to supply a total of 115 million doses through 2025, an increase of approximately 20 million doses, to appropriately support local immunization programs.

“We remain fully committed to the success of our long-standing collaboration with Gavi and UNICEF and are focused on enabling access to our HPV vaccine where some of the most vulnerable populations live,” said Chirfi Guindo, chief marketing officer, MSD. “Central to our purpose at MSD, vaccine equity and access for people in low- and middle-income countries are examples of how we are helping to address some of the world’s most serious health concerns. We have made significant investments in our vaccine production capacity to urgently increase HPV vaccine supply to meet the growing global demand. As a result, we expect to supply sufficient quantities of HPV vaccines to meet anticipated demand for all of our HPV vaccines in 2025 and will continue to expand our supply capacity in the future.”

MSD’s collaboration with Gavi has been in place since the inception of the Alliance. In 2017, MSD entered into a collaboration with Gavi and UNICEF to supply its HPV vaccine in Gavi-eligible countries. Since that time, MSD invested more than $2 billion to quadruple its global supply of HPV vaccines with the proportion supplied to Gavi far outpacing this overall supply growth.

About MSD

At MSD, known as Merck & Co., Inc., Rahway, N.J., USA in the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.msd.com and connect with us on X (formerly Twitter), LinkedIn and YouTube.

Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA

This statement of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2023 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

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RAHWAY, N.J., March 13, 2024 – Our company’s foundation, a private charitable organization funded by MSD (tradename of Merck & Co., Inc., Rahway, N.J., USA), has made an $11 million, six-year (2023 – 2028) commitment to University of New Mexico Health (UNM Health) in support of its new initiative to bring high-quality care to an estimated 11 million people living with cancer in underserved communities throughout India, Indonesia, Malaysia and Vietnam. The new initiative aims to train and mentor more than 33,000 local health workers and is being led by Project ECHO® at UNM Health, a global movement to democratize knowledge and expand access to best-practice care.

This support builds on a $7 million, five-year commitment our company’s foundation made to UNM Health in 2017. Project ECHO used that funding to help improve access to high-quality specialty care for complex chronic conditions, such as hepatitis C, HIV and tuberculosis, and non-communicable diseases, like diabetes, in underserved areas aross India and Vietnam.

Our company’s foundation is committed to advancing global health equity and will continue to support innovative initiatives that aim to improve the health and well-being of people around the world.

About Our Company’s Foundation

Our company’s foundation (Foundation) is a U.S.-based, private charitable organization. Established in 1957 by MSD (tradename of Merck & Co., Inc., Rahway, N.J., USA), a leading global biopharmaceutical company, the Foundation is funded entirely by the company and is MSD’s chief source of funding support to qualified non-profit charitable organizations. Since its inception, the Foundation has contributed more than $1 billion to support important initiatives that address critical global health and societal needs that are consistent with MSD’s purpose: to save and improve lives around the world. For more information, visit www.msd.com/company-overview/sustainability/philanthropy/.

Media Contact:

Olivia Finucane

+44 7881 262476

olivia.finucane@msd.com

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Acquisition broadens oncology pipeline with a portfolio of novel T-cell engagers including HPN328 (MK-6070), an investigational delta-like ligand 3 (DLL3) targeting T-cell engager

RAHWAY, N.J., March 11, 2024 – MSD (tradename of Merck & Co., Inc., Rahway, N.J., USA) (NYSE: MRK) today announced the completion of the acquisition of Harpoon Therapeutics, Inc. (Nasdaq: HARP). Harpoon is now a wholly-owned subsidiary of MSD, and Harpoon’s common stock will no longer be publicly traded or listed on the Nasdaq Stock Market.

“We continue to augment and diversify our oncology pipeline with innovative approaches to help people with cancer worldwide,” said Dr. Dean Y. Li, president, MSD Research Laboratories. “We are pleased to welcome our Harpoon colleagues to MSD and look forward to working together to advance a novel portfolio of T-cell engagers, including MK-6070.”

Harpoon’s lead candidate, MK-6070 (formerly known as HPN328), is a T-cell engager targeting delta-like ligand 3 (DLL3), an inhibitory canonical Notch ligand that is expressed at high levels in small cell lung cancer (SCLC) and neuroendocrine tumors. The safety, tolerability and pharmacokinetics of MK-6070 is currently being evaluated as monotherapy in a Phase 1/2 clinical trial (NCT04471727) in certain patients with advanced cancers associated with expression of DLL3. The study is also evaluating MK-6070 in combination with atezolizumab in certain patients with SCLC. In March 2022, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to MK-6070 for the treatment of SCLC.

Additional pipeline candidates include HPN217, a T-cell engager targeting B-cell maturation antigen (BCMA), currently in Phase 1 clinical development for the treatment of patients with relapsed/refractory multiple myeloma, and several preclinical stage candidates, including HPN601, a conditionally activated targeting epithelial cell adhesion molecule (EpCAM) for the treatment of certain patients with EpCAM expressing tumors.

Transaction details

Under the terms of the merger agreement, MSD, through a subsidiary, has acquired all outstanding shares of Harpoon. As previously disclosed, this transaction is being accounted for as an asset acquisition. MSD is recording a non-tax deductible charge of approximately $650 million of R&D expense. The impact of the transaction on expected full-year non-GAAP EPS is approximately $0.26 per share, which was included in MSD’s full-year 2024 financial outlook issued on February 1, 2024.

MSD’s focus on cancer

Our goal is to translate breakthrough science into innovative oncology medicines to help people with cancer worldwide. At MSD, the potential to bring new hope to people with cancer drives our purpose and supporting accessibility to our cancer medicines is our commitment. As part of our focus on cancer, MSD is committed to exploring the potential of immuno-oncology with one of the largest development programs in the industry across more than 30 tumor types. We also continue to strengthen our portfolio through strategic acquisitions and are prioritizing the development of several promising oncology candidates with the potential to improve the treatment of advanced cancers.

About MSD

At MSD, known as Merck & Co., Inc., Rahway, N.J., USA in the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.msd.com and connect with us on X (formerly Twitter), LinkedIn and YouTube.

Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA

This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2023, and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

MSD Media Contacts:

Robert Josephson

(203) 914-2372

Justine Moore

(347) 281-3754

MSD Investor Contacts:

Peter Dannenbaum

(732) 594-1579

Damini Chokshi

(732) 594-1577

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